The objective of this study is to collect collect real-world data for the Ion endoluminal system.
This is a prospective, observational, multi-center, single-arm study to collect real-world data evaluating procedural characteristics and short- and long-term clinical outcomes following the use of the CE-marked Ion endoluminal system for elective lung nodule biopsies and/or localization procedures. It is a post-market study using the device per the approved indications. All patients will be enrolled per the protocol eligibility criteria. Enrollment for this study will conclude when approximately 1,200 patients have had a nodule biopsy and/or localization procedure attempted or performed.
Study Type
OBSERVATIONAL
Enrollment
1,200
Lung nodule biopsy and/or localization procedure using the Ion endoluminal system per sites' standard of care
Hôpital Marie Lannelongue
Le Plessis-Robinson, France
RECRUITINGHelios Klinikum Emil von Behring
Berlin, Germany
NOT_YET_RECRUITINGUniversitätsspital Zürich
Zurich, Switzerland
RECRUITINGDiagnostic Yield
Diagnostic Yield defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only.
Time frame: Intra-procedure through 24 month post-procedure
Pneumothorax
Defined as the incidence of subjects that undergo an Ion procedure with a pneumothorax event, requiring intervention
Time frame: Intra-procedure through 30 days post-procedure
Bleeding
Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale
Time frame: Intra-procedure through the 30 day post-procedure
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University College London Hospitals NHS Foundation Trust
London, United Kingdom
RECRUITINGWythenshawe Hospital, Manchester University NHS Foundation Trust
Manchester, United Kingdom
RECRUITING